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Simulated Moving Bed (SMB) Chromatography
Complex Emerging Technologies
 Separation and Purification of APIs through SMB Chromatography
SAFC® offers Simulated Moving Bed (SMB) chromatography services starting at early stage materials to commercial-scale capabilities.
SMB chromatography is a cost effective and environmentally friendly technology, using up to 90% less solvent than similar chromatographic purification schemes.
It combines the advantages of high yields, high purity and accelerated scale-up for clinical to commercial-scale API purification. This chiral chromatography based technology works at the molecular level to separate active and non-active enantiomers for active ingredient production.
Small-Scale SMB
Small-scale SMB processing at Buchs, Switzeralnd, covers early-stage material processing for programs requiring purification to 100 g of active product per day.
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CSEP 916 SMB unit from Knauer |
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Column dimensions to 40 mm I.D. |
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cGMP processing available |
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Seamless technology transfer to commercial-scale available |
Commercial-Scale SMB
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First commercial-scale multi-column chromatography unit to be FDA approved for commercial production. |
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One of a few units used for commercial manufacturing |
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9,000 L (100 kg) liquid starting material capacity |
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8,000 L holding reactor tanks |
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1,400 L of concentrated material per batch from processing reactors |
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cGMP production for clinical or commercial products |
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Operates as a Varicol® system |
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Fully automated, back-integrated and temperature controlled |
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Operations on a 24/7 schedule |
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Production train including SMB unit, four glass-lined reactors (3,000 – 8,000 L), Hastelloy® dryer and 2,000 L distillation unit |
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Output production to 40 kg of product/day with operational reliability of 95-98% |
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Six-linked 45 cm diameter purification columns |
 Quality Assurance SAFC has a comprehensive quality assurance program in place for all its processes, including SMB, with:
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Over 53 active DMFs in place |
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Purification to industry cGMP and ICH Q7A standards |
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Commercial-scale system including built in HPLC quality control unit for automated sampling and HPLC quality profiles generation |
Applications
Used when affinity differences between molecules are very small, SMB chromatography is best suited to handle removal steps of a single impurity and can be considered the technology of choice for:
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Enantiomer purification |
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Chiral and other binary-like separations |
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Diastereoisomers |
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